Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.

The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.

Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg

Other Name: Effexor XR

Detailed Description:

Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22% or two to six times higher than in the general population. Depression is linked to a myriad of adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and high rates of suicide. Surprisingly there are no randomized controlled trials for treating major depressive disorder (MMD) in people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding activities may complicate treatment. Treatment trials suggest antidepressants may not be as effective in people with medical/neurological conditions as they are with depression that develops as a primary condition. For almost 20 years clinicians and scientists have called for controlled clinical trials of antidepressants among people with SCI in order to establish evidence-based treatment. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and MDD or dysthymia who are at least one month post injury. Participants aged 18-64 will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life and participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.

Eligibility

Ages Eligible for Study:

18 Years to 64 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Spinal cord injury (ASIA A-D)

At least one month post injury

Meets DSM IV criteria for major depression or dysthymia on the SCID

At least moderately severe depression (PHQ-9 score >= 10)

Within reasonable travel distance to one of the study sites

Exclusion Criteria:

Current DSM IV alcohol or drug dependence

History of bipolar disorder or psychosis

History of >= 2 suicide attempts or suicide attempt with 5 years

Current suicidal intent or plan

Medical contraindications

Non-English speaker

Clinically significant cognitive/language impairment

History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks

Current use of antidepressant medications (will not exclude if on low dose of a tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for depression, or electroconvulsive therapy

Pregnant or lactating women or women of childbearing potential who are not willing to use a reliable form of contraception

Anticipated major surgical procedures within the 12 weeks of randomization

Use of an investigational drug within 30 days

Use of psychoactive medications, including corticosteroids and anticonvulsants, that have not been at a stable dose for at least 2 weeks

Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance (including St. John's Wort) within 7 days of start of double-blind treatment. If the patient is taking a sedative deemed necessary for sleep induction or spasticity, the dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are permitted if at a stable dose for at least 2 weeks.

Refusal to participate

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592384

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35294-0111

United States, Florida

University of Miami

Miami, Florida, United States, 33124

United States, Illinois

Rehabilitation Institute of Chicago

Chicago, Illinois, United States, 60611-2654

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109-0491

United States, Texas

Baylor Institute for Rehabilitation

Dallas, Texas, United States, 75246

United States, Washington

University of Washington/Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

University of Michigan

Rehabilitation Institute of Chicago

University of Alabama at Birmingham

Baylor Health Care System

University of Miami

New York University

Investigators

Principal Investigator:

Charles H. Bombardier, PhD

University of Washington School of Medicine, Department of Rehabilitation Medicine

Principal Investigator:

Jesse R. Fann, MD, MPH

University of Washington School of Medicine, Department of Psychiatry and Behavioral Science